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Clinical Research Services: regulatory support

Physical
Pricing/Discount Options: Call #2
Unique Identifier: 117236b0-6987-4c43-8198-d5854789b2d3

Service Description

Submission to the French regulatory authorities (Ethical committee CPP, ANSM, CNIL); feedback management with these regulatory authorities to take into account their requirements.

Offerings: Ethics & Regulatory Affairs (ethics board approval, legal requirements, ...) Testing Clinical (investigation, trial, etc.) Clinical Investigation Support (clinical studies & trials, coordination, design, feasibility, documentation, compliance, operations support, etc.)
TEF-Health Use Case Domain: All
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Provider & Contact

Provider Organisation Centre Hospitalier Universitaire De Rennes (CHU RENNES)
Provider Country France
Published Email tef-health@chu-rennes.fr

Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.

Operational Details

Service Inputs The clinical protocol has been written (academic or company sponsoring)
Service Outputs Obtaining authorizations
Dependencies & Restrictions Authorized protocol
Service Standards EU Regulation 2017/745; Good Clinical Practise; European Clinical Research Infrastructure Network (ECRIN) label
  • EU Regulation 2017/745
  • European Clinical Research Infrastructure Network (ECRIN) label
  • Good Clinical Practise

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